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FDA accepts sBLA for Merck’s KEYTRUDA® (pembrolizumab) plus chemotherapy for advanced or unresectable biliary tract cancer

Jun 8, 2023

Merck announced the US Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin chemotherapy for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).